Micronutrient Supplementation in in Paediatric Pulmonary Tuberculosis

NCT00801606 | Completed Phase 3 DMC

• 1 other identifier: ICTBSG
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 1

Brief Summary

A recent trial in adults has demonstrated that zinc (Zn) and other Multiminerals (MN) combined, but neither of them alone, significantly increased weight gain during Tuberculosis (TB) treatment. There was a substantially larger beneficial effect on survival amongst those who received the combination of Zn and MN compared with those who received either Zn alone or MN alone. These exciting preliminary findings require further confirmation, as the data on mortality reduction was based on a post-hoc subgroup-analysis. Effects of MN and Zn supplementation has not been assessed in children with TB. Studies are urgently needed to evaluate the therapeutic potential of nutritional interventions on treatment outcome in children with TB. Simple and inexpensive nutritional interventions may substantially impact TB-related child morbidity and mortality in high-burden settings. The investigators thus, propose a randomized, double blind, controlled trial that will measure the effect of multi-vitamin/mineral supplementation on the efficacy of anti-TB treatment in newly diagnosed childhood pulmonary TB patients in Delhi.

Conditions

Tuberculosis

Keywords

Micronutrient; Childhood Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Change in Z score for weight and improvement in X ray film

  6 months

Secondary Outcomes (1)

• Resolution of symptoms and interferon gamma activity at 2 and 6 months

  6 months

Study Arms (4)

Study drug containing zinc alone

EXPERIMENTAL

Zinc 20 mg daily

Drug: Zinc

Study drug Micronutrient without zinc

EXPERIMENTAL

micronutrients (vitamin A, thiamine, riboflavin, vitamins B-6 and B-12, folic acid, niacin, vitamins C, E, and D, selenium, and copper) without zinc.

Drug: Micronutrient without zinc

Study drug Micronutrient with zinc

EXPERIMENTAL

micronutrients in combination with zinc (vitamin A, thiamine, riboflavin, vitamin B-6 and B-12, folic acid, niacin, vitamins C, E, and D, selenium, copper, and 20 mg elemental zinc).

Drug: Micronutrient with zinc

Placebo

PLACEBO COMPARATOR

Placebo only

Drug: Placebo

Interventions

Zinc DRUG

Zinc 20 mg/day

Also known as: study drug

Study drug containing zinc alone

Micronutrient without zinc DRUG

Multimineral 2 RDA

Also known as: study drug

Study drug Micronutrient without zinc

Micronutrient with zinc DRUG

Multimineral 2 RDA and zinc 20 mg per day

Also known as: study drug

Study drug Micronutrient with zinc

Placebo DRUG

Placebo

Also known as: study drug

Placebo

Eligibility Criteria

• Age: 6 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• New pulmonary (including pleural) tuberculosis with/without an extrapulmonary lesion in children age 6 months to 15 years

You may not qualify if:

• Weight for height \< 70 % of NCHS median (reason: zinc as per guidelines is given as standard point of care to all severely malnourished children)
• Bilateral pedal oedema
• Known HIV + ve
• Place of residence outside Delhi (including physicians discretion)
• History of previous ATT treatment or INH prophylaxis for more than 48 hours prior to enrollment
• Signs of upper airway obstruction, or an arterial oxygen saturation less than 92% in room air
• Signs of renal, hepatic, or cvs disease
• Unable to attend follow up session for reading of Mantoux tests
• Documented intake of zinc continuously for \> 2 weeks in the preceding 4 weeks at enrollment
• CNS, osteo-articular, pericardial, renal TB
• History of contact with a documented case of drug resistant TB

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• University of Bergen: collaborator

Study Sites (1)

Department of Pediatrics, All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (1)

• Lodha R, Mukherjee A, Singh V, Singh S, Friis H, Faurholt-Jepsen D, Bhatnagar S, Saini S, Kabra SK, Grewal HM; Delhi Pediatric TB Study Group. Effect of micronutrient supplementation on treatment outcomes in children with intrathoracic tuberculosis: a randomized controlled trial. Am J Clin Nutr. 2014 Nov;100(5):1287-97. doi: 10.3945/ajcn.113.082255. Epub 2014 Sep 10.

  PMID: 25332327 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Zinc; Drug Evaluation; Micronutrients

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Drug Development; Investigative Techniques; Evaluation Studies as Topic; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Sushil Kr Kabra, MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: December 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 10, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)